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Lung CancerPhase 1NCT06232083

A Multi Tumor, Open Phase I Clinical Study on the Progression of First-line Anti-tumor Therapy Using Cardonizumab Combined With Pulsed Low-dose Rate External Irradiation (PLDR)

A Phase 1 study testing PLDR+Cardunizumab in people with Lung Cancer and Esophageal Cancer, run by Anhui Provincial Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

At present, the treatment methods for recurrent cancers are very limited. The immune checkpoint inhibitors (ICBs) is a promising new directions for recurrent lung cancer/ esophageal cancer / cervical cancer, but the clinical response rate is insufficient. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Lung Cancer, Esophageal Cancer, Cervical Cancer
What is being tested?
PLDR+Cardunizumab
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Sep 2025to 1 Sep 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients must meet all the following criteria to be enrolled:
  • The subjects voluntarily joined the study, signed informed consent, had good compliance and were willing to cooperate with the follow-up;
  • There is no limit for men and women, ranging in age from 18 to 75 years old (including 18 and 75 years old);
  • Pathologically confirmed esophageal cancer, lung cancer or cervical cancer;
  • The expected survival time was more than 3 months;
  • Recurrent or metastatic patients with previous treatment progress;
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  • ECoG 0-2 points;
  • According to RECIST 1.1 standard, there was at least one extracranial measurable lesion;
  • The laboratory test results within one week before enrollment meet the following conditions: 1) blood routine: HGB≥90g/L； WBC ≥ 4.0 × 109/L; Neut ≥ 2.0 × 109/l; PLT ≥ 100 × 109/l; 2) Blood biochemistry: TBIL ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN (ALT and AST ≤ 5 × ULN in patients with liver metastasis); Bun and Cr ≤ 1.5 × ULN and creatinine clearance rate ≥ 50 ml/min; 3) The results of echocardiography within two weeks before admission were consistent: left ventricular ejection fraction (LVEF)>50%;
  • The coagulation function was normal without active bleeding and thrombosis;
  • Patients without contraindications to radiotherapy;
  • The pregnancy test of patients of childbearing age was negative, and they voluntarily took effective and reliable contraceptive measures during the test;
  • Subjects who have received anti-tumor treatment in the past should not be enrolled until the toxicity of previous treatment has stabilized and returned to the baseline level (except for the residual hair loss effect) or the CTCAE V5.0 score ≤ 1.

Who cannot join

  • If the patient meets any of the following conditions, he cannot be selected:
  • Patients with malignant tumors other than esophageal cancer, lung cancer and cervical cancer;
  • Patients with other active malignant tumors in the first 5 years of randomization, such as squamous cell carcinoma of the skin, basal cell carcinoma of the skin, superficial bladder cancer, and breast cancer in situ, except those with locally curable tumors that have been cured;
  • Patients who had participated in clinical trials of other drugs within 4 weeks before enrollment, and who had received radiotherapy for the target area within 4 weeks before entering this study, were vaccinated with live attenuated vaccine within 4 weeks before the first administration or during the study period;
  • Arteriovenous thrombosis events occurred within 6 months, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism, etc;
  • Receiving any other anti-tumor treatment at the same time;
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  • Those who are known to have a history of allergy to the drug components of this protocol have a history of telangiectatic ataxia or other radiation hypersensitivity;
  • Subjects with active infectious diseases;
  • Subjects with any severe and/or uncontrolled disease;
  • Female patients during pregnancy and lactation, female patients with fertility and positive baseline pregnancy test;
  • According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study (including but not limited to severe hypertension, severe pulmonary dysfunction/disease and severe diabetes that cannot be controlled by drugs);
  • Having a clear history of neurological or mental disorders, including epilepsy or dementia, and unable to cooperate with the radiotherapy process;
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
  • Diagnosed with immune deficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy, and suffering from active or recurrent autoimmune diseases, except for vitiligo, alopecia, psoriasis or eczema that do not require systematic treatment; Hypothyroidism caused by autoimmune thyroiditis only needs a stable dose of hormone replacement therapy; Type I diabetes requiring only a stable dose of insulin replacement therapy;
  • Have active or documented inflammatory bowel disease (such as Crohn's disease, ulcerative colitis), and active diverticulitis. The clinical manifestations of gastrointestinal obstruction, or the need for conventional parenteral fluid infusion, parenteral nutrition or indwelling gastric tube;
  • There were symptomatic central nervous system (CNS) metastasis, leptomeningeal metastasis or spinal cord compression caused by metastasis before signing the informed consent. Those without clinical symptoms, who have clinical and/or imaging evidence indicating stable condition, and who stop corticosteroids and anticonvulsant drugs for at least 2 weeks can participate in the study;
  • At present, there are patients with effusion in the third space who need repeated puncture and drainage and other local treatment with poor clinical control;
  • Subjects with any of the following cardiovascular diseases were excluded:
  • Myocardial infarction, unstable angina pectoris, pulmonary embolism, acute/persistent myocardial ischemia, cerebrovascular accident, transient ischemic attack, or other arteriovenous thrombosis, embolism or ischemic events with clinical significance/requiring drug treatment intervention occurred within 6 months before the first administration;
  • Previous and/or current NYHA III-IV congestive heart failure;
  • Previous and/or current severe arrhythmias requiring medical treatment;
  • Before the first administration, 12 lead ECG showed that the mean QT interval (QTCF)>470 Ms.
  • The investigator believes that the patient is not suitable for any other circumstances in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • The First Affiliated Hospital of University of Science and Technology of China

    Hefei, British Columbia, 230001

    Peijie Zhou, doctor, +8618356148326, zhpejie@ustc.edu.cn

    Recruiting

Other trials in China

About this study

At present, the treatment methods for recurrent cancers are very limited. The immune checkpoint inhibitors (ICBs) is a promising new directions for recurrent lung cancer/ esophageal cancer / cervical cancer, but the clinical response rate is insufficient. Pulse low-dose rate radiotherapy (PLDR) is a new technology in recent years, which uses continuous pulse low-dose rate irradiation to induce hypersensitivity in tumors, and its clinical safety has been verified. Compared to conventional radiotherapy, PLDR has advantages in protecting the lymphatic system and relieving the immune barrier, but it is still unclear whether it can improve the efficacy of ICB. This project aims to combine PLDR with ICB to explore new strategies for recurrent patients.

Being tested
PLDR+Cardunizumab
Medical subject headings
Lung Neoplasms, Esophageal Neoplasms, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PLDR+CardunizumabRadiation

    Application of PLDR external irradiation combined with Cardunizumab in recurrent lung cancer, esophageal cancer and cervical cancer.

Study groups in NCT06232083
Study groupRoleWhat they receive
PLDR+CadonilimabExperimental1. PLDR: 40Gy/20f; GTV is the recurrence or metastasis lesion with clear imaging (the radiotherapy lesion is determined by the researcher, and the first-line treatment is preferred for the advanced lesion). CTV is the appropriate expansion of GTV by 0.5cm-0.7cm, including the related lymphatic drainage area (such as neck and pelvic cavity) if necessary. 2. ICB was performed during the external irradiation of PLDR, and cadunizumab 6mg/kg was given for 2 weeks; After the external irradiation of PLDR, cardunilimab was maintained at the dose of 10mg/kg for 3 weeks. Maintenance treatment for 2 years.
Receives: Radiation: PLDR+Cardunizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    Objective response rate，The proportion of patients whose tumor volume shrinks by 30% and can be maintained for more than four weeks, which is the sum of complete remission and partial remission (CR+PR)

    Measured: 6 month post PLDR external irradiation

Secondary outcomes (1)

  1. TEAE

    Treatment Emergent Adverse Event

    Measured: 6 month post PLDR external irradiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2024
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06232083
Sponsor's protocol ID
Zhou peijie-2024ky-05
Status last verified
Jul 2025
First submitted
16 Jan 2024
Last updated
9 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PLDR+Cardunizumab in people with Lung Cancer and Esophageal Cancer, run by Anhui Provincial Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 6 month post PLDR external irradiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06232083.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.

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Clinical Trial NCT06232083 | AzTrials